(104 days)
The Synthes 2.7 mm/ 3.5 mm VA-LCP Anterior Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.
The Synthes 2.7 mm / 3.5 mm VA-LCP Anterior Clavicle Plate System consists of plates of various lengths and variable angle screws that provide the flexibility to lock screws in trajectories that can diverge from the central axis of the plate hole. The system features medial and lateral plates that are precontoured to match the anatomy of the clavicle and a limited contact, low profile design. The plate with lateral extension features Variable Angle (VA) Locking holes and Dynamic Compression Plate (DCP) holes. The medial plate features Dynamic Compression Plate (DCP) holes combined with VA locking screw holes.
The provided document describes a 510(k) premarket notification for a medical device, the Synthes 2.7/3.5mm VA-LCP Anterior Clavicle Plate System. This is a bone fixation appliance used in orthopedic surgery, not a diagnostic or AI-driven device.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/diagnostic device is not applicable directly to this submission. The "acceptance criteria" here relate to demonstrating substantial equivalence to predicate devices for regulatory approval, primarily through mechanical testing and comparison of design characteristics.
Here’s an adaptation of your requested table and information, focusing on what is available in the document for this type of medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance (Adapted for Medical Device Equivalence)
| Acceptance Criteria (for Substantial Equivalence to Predicates) | Reported Device Performance (Synthes 2.7/3.5mm VA-LCP Anterior Clavicle Plate System) |
|---|---|
| Indications for Use: Comparable to predicate devices, with potential for broader indications if justified. | Same as predicate, with an added pediatric indication (adolescents 12-21 years with fused growth plates or plates not crossing growth plates). |
| Technological Characteristics: Similar materials, design features, and functionality to predicate devices. | - Machined metal plates (same alloys as predicates). |
- Pre-contoured for the clavicle.
- Incorporate combination dynamic compression/threaded locking screw holes.
- Similar geometric dimensions (thickness, shaft width, overall length, number of screw holes).
- Limited contact designs.
- Allow additional contouring.
- Allow the same size cortex, locking cortex, and cancellous screws. |
| Performance (Mechanical/Engineering): Equivalent or superior mechanical performance to predicate devices in relevant tests. | Static Compression ultimate load strength testing: Showed "much higher bending strength" than predicate plate systems.
Engineering Calculations: Confirmed bending strength is "greater than the bending strength of the predicate plate system." |
| Safety and Effectiveness: Presents no new issues of safety or effectiveness compared to predicate devices. | Based on design characteristics and test results, the device "presents no new issues of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for the "Static Compression ultimate load strength testing." It refers to "the proposed plate system (plate/screw construct)" and "the predicate plate systems" in a general sense, implying typical engineering test runs but not providing specific numbers of constructs tested.
- Data Provenance: The testing and engineering analysis were performed by Synthes (USA), a medical device manufacturer. This data is part of their internal validation and verification processes for their product development.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- This concept is not directly applicable to this type of device submission. The "ground truth" for mechanical testing is established by engineering standards, test methods, and material science principles, not by expert consensus in a clinical sense. The experts involved would be engineers, material scientists, and regulatory affairs personnel within Synthes and at the FDA, reviewing the data against established benchmarks for mechanical stability and equivalence.
4. Adjudication Method for the Test Set
- Not applicable in the AI/diagnostic sense. Mechanical testing results are objective measurements against defined criteria. Any "adjudication" would involve review by subject matter experts (engineers) to ensure test protocols were followed and results interpreted correctly, but not a concensus process like for clinical image interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is relevant for diagnostic devices where human interpretation needs to be compared or augmented by an AI. This submission is for a bone fixation plate, which is a surgical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This refers to an AI algorithm's performance without human interaction. This device is a passive mechanical implant.
7. The Type of Ground Truth Used
- The "ground truth" for establishing substantial equivalence for this device is based on objective mechanical performance metrics (e.g., ultimate load strength, bending strength) derived from standardized engineering tests (e.g., static compression testing) and comparative analysis of design and material properties against legally marketed predicate devices.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device that requires a training set. The design of the plate is based on anatomical considerations and biomechanical engineering principles, informed by previous product development and clinical experience with bone fixation.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set in the AI sense, there is no corresponding ground truth establishment process.
Summary of the Study Proving Device Meets "Acceptance Criteria" for Substantial Equivalence:
The document indicates that the Synthes 2.7/3.5mm VA-LCP Anterior Clavicle Plate System demonstrated substantial equivalence through:
- Comparison of Design Characteristics: The device shares core technological characteristics, materials (same alloys), and geometric aspects with its predicate devices (Synthes 3.5mm LCP Reconstruction Plate System, K000684, and Synthes 3.5mm LCP Superior Anterior Clavicle Plate System, K073186). This includes features like pre-contoured plates, combination screw holes, limited contact designs, and compatibility with standard screws.
- Mechanical Testing and Engineering Analysis:
- Static Compression ultimate load strength testing was performed on plate/screw constructs.
- Engineering Calculations were used to further confirm performance.
- These tests showed that the proposed plate system exhibited "much higher" and "greater" bending strength compared to the predicate plate systems.
These lines of evidence, reviewed by the FDA, supported the conclusion that the device is substantially equivalent to the predicates and presents no new issues of safety or effectiveness, allowing for its 510(k) clearance.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.